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Surgical Masks - Premarket Notification [510(k)] Submissions

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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Respirator and Surgical Mask Comparison - Moldex

Purpose Or Intended Use

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Dasheng Health Products Manufacturing

The company passed the ISO9001 international quality management system certification. Dasheng masks dozens of models for the European standard EN149 and get FFP1, FFP2 and FFP3 qu

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